The paper, entitled Buccal spray insulin in subjects with
impaired glucose tolerance: the prevoral study, appears in Volume
13, Issue 1 (January 2011) of the journal and is co-authored by a
team from the Department of Endocrinology and Diabetes, University
Campus Bio-Medico, Rome, Italy led by Professor Paolo Pozzilli and
including: A. Palermo, N. Napoli, S. Manfrini, A. Lauria, and R.
Strollo.

People affected by impaired glucose tolerance (IGT) represent
more than 20% of the world's population and the prevalence of the
condition is growing. Approximately one-third of people with IGT
develop clinical type 2 diabetes mellitus within three to five
years of an IGT diagnosis. More significantly, an increased risk
for cardiovascular disease has been observed in IGT patients, even
where type 2 diabetes does not develop. Although diet and exercise
(the treatment for IGT suggested by current American Diabetes
Association guidelines) delay the onset of type 2 diabetes,
long-term prospects are poor.

Because a reduced first phase insulin response is a key factor
in diagnosing IGT, the use of insulin therapy to reduce
post-prandial glucose levels could be a targeted treatment for IGT.
However, insulin therapy via subcutaneous injection is often
rejected by patients and its use is generally limited to patients
with type 2 diabetes where oral hypoglycaemic options have
failed.

In Professor Pozzilli's proof-of-concept study, 31 subjects
diagnosed with IGT, with a mean age of 52 years, and a body mass
index of 33 (i.e. obese) received Generex Oral-lyn(TM) in equal
doses before and 30 minutes after drinking 75 grams of glucose in a
standard oral glucose tolerance test. Glucose and insulin levels
were measured at baseline and 30, 60, 90, 120, and 180 minutes
after consuming the glucose. Treatment with an aggregate of 12
Generex Oral-lyn(TM) sprays resulted in a 29.6% decrease in plasma
glucose at two hours and a 26.8% decrease at three hours. Overall,
the study found a mean reduction in glucose levels of 15.8%. Plasma
insulin was also significantly increased at 30 minutes but not at 2
hours or 3 hours, demonstrating the important increase in first
phase insulin availability.

The study demonstrates that treatment with Generex Oral-lyn(TM)
is a simple and valuable therapy for reducing post-prandial
hyperglycaemia in obese subjects with IGT. Importantly, the
treatment is safe and no subject experienced hypoglycaemia.
Professor Pozzilli commented that: "The results of this study are
of particular interest because they demonstrate that Generex
Oral-lyn(TM) could be successfully employed to normalize
post-prandial glucose levels in subjects with IGT. The convenience
of buccal absorption of insulin in subjects with IGT may represent
a significant advantage in terms of therapeutic compliance."

Dr. James Anderson, a member of the Generex Scientific Advisory
Board, noted that "This study is the first demonstration of
directly increasing first phase insulin levels and reducing post
prandial glucose using a non-invasive therapy. The potential to use
Generex Oral-lyn(TM) as a frontline treatment for patients with IGT
could have far reaching implications. If such a non-invasive
therapy delayed the onset of diabetes along with all of its
complications, it could eventually become a cost effective
alternative to allowing the condition to progress with just diet
and exercise."

As a result of these important findings, a second trial
(Prevoral 2) is underway where subjects with IGT are being treated
for six months with either (a) Generex Oral-lyn(TM) + diet and
exercise, or (b) the standard IGT treatment of only diet and
exercise. The end-point of the Prevoral 2 study is represented by
glycated haemoglobin values. Initial promising data were presented
in September at the 46th Congress of the European Association of
the Study of Diabetes in Stockholm, Sweden. Final results of the
Prevoral 2 study will be available in mid-2011.

About Generex Biotechnology Corporation

Generex is engaged in the research, development, and
commercialization of drug delivery systems and technologies.
Generex has developed a proprietary platform technology for the
delivery of drugs into the human body through the oral cavity (with
no deposit in the lungs). The Company's proprietary liquid
formulations allow drugs typically administered by injection to be
absorbed into the body by the lining of the inner mouth using the
Company's proprietary RapidMist(TM) device. The Company's buccal
insulin spray product, Generex Oral-lyn(TM), which has been
approved in India, Lebanon, Algeria, and Ecuador for the treatment
of subjects with Type-1 and Type-2 diabetes, is in Phase III
clinical trials at several sites around the world. Antigen Express,
Inc. is a wholly owned subsidiary of Generex. The core platform
technologies of Antigen Express comprise immunotherapeutic vaccines
for the treatment of malignant, infectious, allergic, and
autoimmune diseases. For more information, visit the Generex
www.generex.com or the Antigen Express
website at www.antigenexpress.com

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